Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures
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| ClinicalTrials.gov Identifier: NCT04597268 |
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Recruitment Status :
Recruiting
First Posted : October 22, 2020
Last Update Posted : January 10, 2022
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Sponsor:
National Cancer Institute, Egypt
Information provided by (Responsible Party):
Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
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Brief Summary:
This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sedation and Analgesia | Drug: Dexmedetomidine Drug: Ketamine Drug: Midazolam | Not Applicable |
Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients |
| Actual Study Start Date : | November 1, 2020 |
| Estimated Primary Completion Date : | February 10, 2022 |
| Estimated Study Completion Date : | February 25, 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: dexmedetomidine
IV dexmedetomidine
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Drug: Dexmedetomidine
intravenous dexmedetomidine 1 mic/kg
Other Name: propofol- dexmedetomidine |
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Experimental: ketamine
IV ketamine
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Drug: Ketamine
ketamine 1mg/kg
Other Name: propofol- ketamine |
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Active Comparator: Midazolam
IV midazolam
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Drug: Midazolam
midazolam 0.05 mg/kg
Other Name: propofol- midazolam |
Primary Outcome Measures :
- Ramsy sedation score (RSS) [ Time Frame: 3 to 6 months ]time to achievement of Ramsy sedation score (RSS) 3-4, Ramsy sedation scale score from 1 to 6, 1 meaning anxious and 6 meaning no response to stimulus
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients scheduled for gastrointestinal endoscopic procedures
- ≥ Age 18 years
- ASA I-II
Exclusion Criteria:
- Allergy to any of the used drugs
- impaired renal or liver functions
- hypertensive patients
- patients with cardiovascular
- cerebrovascular disease
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597268
Contacts
| Contact: Walaa Y Elsabeeny, MD | 01007798466 ext 002 | walaa.elsabeeny@nci.cu.edu.eg | |
| Contact: Nahla N Shehab, MD | 01221682808 ext 002 | nahla.shehab2@gmail.com |
Locations
| Egypt | |
| Walaa Y Elsabeeny | Recruiting |
| Cairo, Egypt, 11796 | |
| Contact: Walaa Y Elsabeeny, MD 01007798466 ext 002 Walaa.elsabeeny@nci.cu.edu.eg | |
| Contact: Nahla N Shehab, MD 01221682808 ext 002 Nahla.shehab2@gmail.com | |
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
| Principal Investigator: | Walaa Y Elsabeeny, MD | Lecturer | |
| Study Director: | Nahla Y Shehab, MD | Lecturer |
| Responsible Party: | Walaa Youssef Elsabeeny, Lecturer of anesthesia and pain management, National Cancer Institute, Egypt |
| ClinicalTrials.gov Identifier: | NCT04597268 |
| Other Study ID Numbers: |
AP2007-50110 |
| First Posted: | October 22, 2020 Key Record Dates |
| Last Update Posted: | January 10, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Data available upon reasonable request through contacting the corresponding author |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Midazolam Dexmedetomidine Ketamine Propofol Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists |
Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anesthetics, Dissociative Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents |